TY  - JOUR
PY  - 2021//
TI  - A pragmatic clinical trial approach to assessing and monitoring suicidal ideation: results from a national US trauma care system study
JO  - Psychiatry interpersonal and biological processes
A1  - Engstrom, Allison
A1  - Moloney, Kathleen
A1  - Nguyen, Jefferson
A1  - Parker, Lea
A1  - Roberts, Michelle
A1  - Moodliar, Rddhi
A1  - Russo, Joan
A1  - Wang, Jin
A1  - Scheuer, Hannah
A1  - Zatzick, Douglas
SP  - ePub
EP  - ePub
VL  - ePub
IS  - ePub
N2  - OBJECTIVE: Few investigations have comprehensively described methods for assessing and monitoring suicidal ideation in pragmatic clinical trials of mental health services interventions. This investigation's goal was to assess a collaborative care intervention's effectiveness in reducing suicidal ideation and describe suicide monitoring implementation in a nationwide protocol. <br><br>METHOD: The investigation was a secondary analysis of a stepped wedge cluster randomized trial at 25-Level I trauma centers. Injury survivors (N = 635) were randomized to control (n = 370) and intervention (n = 265) conditions and assessed at baseline hospitalization and follow-up at 3-, 6- and 12-months post-injury. The Patient Health Questionnaire (PHQ-9) item-9 was used to evaluate patients for suicidal ideation. Mixed model regression was used to assess intervention versus control group changes in PHQ-9 item-9 scores over time and associations between baseline characteristics and development of suicidal ideation longitudinally. As part of the study implementation process assessment, suicide outreach call logs were also reviewed. <br><br>RESULTS: Over 50% of patients endorsed suicidal ideation at ≥1 assessment. Intervention patients relative to control patients demonstrated reductions in endorsements of suicidal ideation that did not achieve statistical significance (F[3,1461] = 0.74, P = .53). The study team completed outreach phone calls, texts or voice messages to 268 patients with PHQ-9 item-9 scores ≥1 (n = 161 control, n = 107 intervention). <br><br>CONCLUSIONS: Suicide assessment and monitoring can be feasibly implemented in large-scale pragmatic clinical trials. Intervention patients demonstrated less suicidal ideation over time; however, these comparisons did not achieve statistical significance. Intensive pragmatic trial monitoring may mask treatment effects by providing control patients a supportive intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT02655354.<p />  <p>Language: en</p>
LA  - en
SN  - 0033-2747
UR  - http://dx.doi.org/10.1080/00332747.2021.1991200
ID  - ref1
ER  -